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临床试验/CTRI/2026/02/104116
CTRI/2026/02/104116尚未招募Unknown

Comparison of Fluoride Mouth rinse and Chlorhexidine for prevention of white spot lesions during fixed orthodontic treatment: Prospective blinded randomized controlled trial

Multidisciplinary Research UnitMRU Rajendra Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年3月2日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
The primary outcome will be estimation of White spot lesion on patient level assessed from digital photographs.

研究概览

简要总结

The present study will be planned to know the efficacy of Fluoride mouth rinse in prevention of white spot lesion in patients undergoing fixed multibracket orthodontic treatment. The present study will be to know which is better mouth rinse for prevention of white spot lesion in patient undergoing fixed multi-bracket orthodontic treatment. The oblective of trial is to determine efficacy of mouthrinse in reduction of white spot lesion.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
14.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • The patient appointment given for fixed orthodontic treatment.
  • The patient having age group of 14 to 25, having good oral hygiene.
  • The patient having no habit of smoking with no systemic medical condition.

排除标准

  • Those patients received previous orthodontic treatment.
  • More than 2 carious cavity
  • Enamel abnormality prior to treatment
  • Any Pregnant female or Mentally retarded patient.

结局指标

主要结局

The primary outcome will be estimation of White spot lesion on patient level assessed from digital photographs.

时间窗: 6 month of orthodontic treatment with use of mouthrinse at night time.

The white spot lesion index9 (Gorelick et al,1982)

时间窗: 6 month of orthodontic treatment with use of mouthrinse at night time.

0-No visible white spot lesion (No demineralization)

时间窗: 6 month of orthodontic treatment with use of mouthrinse at night time.

1-Visible WSL that covered less than 1/3rd of the tooth surface.(Mild demineralization)

时间窗: 6 month of orthodontic treatment with use of mouthrinse at night time.

2-Visible WSL that covered more than 1/3rd of the tooth surface, with a roughened surface.(Moderate demineralization)

时间窗: 6 month of orthodontic treatment with use of mouthrinse at night time.

3-Visible cavitations requiring restoration.( Severe demineralization)

时间窗: 6 month of orthodontic treatment with use of mouthrinse at night time.

次要结局

  • Bleeding from Gum(6 month of Fixed orthodontic Treatment)

研究者

发起方
Multidisciplinary Research UnitMRU Rajendra Institute of Medical Sciences
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Awanindra Kumar Jha

Rajendra Institute of Medical Sciences

研究点 (1)

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